New China NMPA Reform titled “Regulation on the Supervision and Administration of Medical Devices”, or Order 739, long-awaited overarching policy, is finally released. It was adopted by the China State
Here’s the latest China regulatory and clinical affairs newsletter for medical device and IVDs pros in February 2021. These updates are presented by China Med Device, LLC, your partner in
An amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted by the China State Council on December 22, 2020. On March 16, 2021 the amendment
The NMPA released the Annual Report for Medical Device Registration on February 5, 2021. In 2020, the NMPA accepted a total of 10,579 medical device initial registrations, registration renewals and
On January 25, 2021 the China National Health Commission issued the Technical Guideline for COVID-19 Prevention and Control on Manufacturers and Suppliers of Imported Products. Mentioned in the guidelines, “the
The NMPA announced its preparation of “Technical Review Guideline of Diagnostic Software for Diabetic Retinopathy (DR)” and “Technical Review Guideline of Image Ultrasonic Diagnostic Based AI Software” for public comments on
China’s UDI system for the submission of the first group of devices will take effect on January 1, 2021. For the medical devices listed in the “First Group of Unique Device
Fourteen medical devices and three drugs are piloting in the Real-World Data Hainan program, according to RWD Initiation Meeting in Beijing on December 28, 2020. It’s the second group of
Historical changes of medical device industry has been made in China. Amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted by the China State Council
A “Beijing Medical Ethics Committee (EC) Review Mutual Recognition Alliance” was formed on December 1, 2020. The mutual recognition alliance currently consists of fifteen member institutes. It will greatly accelerate
Unapproved medical devices can be clinically used in China’s Big Bay Area of Guangdong, Hong Kong, and Macao with over 70 million people. As long as they are used in
The NMPA granted Innovation Approval for a Peripheral Drug-Eluting PTA Balloon Catheter produced by Zylox Medical on November 11, 2020. For the NMPA Innovation Device Review Report on the Peripheral Drug-Eluting
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